Device Classification Name |
system, catheter control, steerable
|
510(k) Number |
K221464 |
Device Name |
CorPath GRX System |
Applicant |
Corindus, Inc. |
309 Waverley Oaks Road, Suite 105 |
Waltham,
MA
02452
|
|
Applicant Contact |
Robert Lavado |
Correspondent |
Corindus, Inc. |
309 Waverley Oaks Road, Suite 105 |
Waltham,
MA
02452
|
|
Correspondent Contact |
Robert Lavado |
Regulation Number | 870.1290
|
Classification Product Code |
|
Date Received | 05/19/2022 |
Decision Date | 07/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|